DISE-HNS Effect Study

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Hypoglossal nerve stimulation implant; Diagnostic Test: Polysomnography; Procedure: Drug-induced sleep endoscopy (DISE)

• Registration Number: NCT06372847
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.

Furthermore, outcomes will be compared between responders and non-responders.

Detailed Description

Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE.

To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation.

All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway.

One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Study Start: 2024-04-23
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• 18 years or older.
• Eligible for HNS-therapy:
• AHI between 15 and 65 events/hour
• BMI under 32 kg/m2
• Absence of complete concentric collapse of palate (CCC) on DISE
• Intolerance or failure of continuous positive airway pressure (CPAP)-treatment
• Intolerance or failure of mandibular advancement device (MAD)-treatment
• Combination of central and mixed apneas less than 25% of total apneas on recent PSG (not older than two years)
• Scheduled for HNS-implantation at the Antwerp University Hospital
• Capable of giving informed consent
• Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital

Exclusion Criteria

• Patients will not receive HNS-therapy at the Antwerp University Hospital
• Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Receiving hypoglossal nerve stimulation (HNS)	Hypoglossal nerve stimulation implant	All included patients will be part of this arm. Patients who are eligible for HNS-therapy for obstructive sleep apnea (OSA) will be invited to participate in the study. Data from the baseline PSG and baseline DISE as part of the standard pathway for HNS-eligibility will be accessed and collected. All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway. After one year of treatment, information from the one-year follow-up PSG as part of the standard pathway will be collected. Furthermore, patients will undergo an additional one-year follow-up DISE.
Receiving hypoglossal nerve stimulation (HNS)	Polysomnography	All included patients will be part of this arm. Patients who are eligible for HNS-therapy for obstructive sleep apnea (OSA) will be invited to participate in the study. Data from the baseline PSG and baseline DISE as part of the standard pathway for HNS-eligibility will be accessed and collected. All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway. After one year of treatment, information from the one-year follow-up PSG as part of the standard pathway will be collected. Furthermore, patients will undergo an additional one-year follow-up DISE.
Receiving hypoglossal nerve stimulation (HNS)	Drug-induced sleep endoscopy (DISE)	All included patients will be part of this arm. Patients who are eligible for HNS-therapy for obstructive sleep apnea (OSA) will be invited to participate in the study. Data from the baseline PSG and baseline DISE as part of the standard pathway for HNS-eligibility will be accessed and collected. All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway. After one year of treatment, information from the one-year follow-up PSG as part of the standard pathway will be collected. Furthermore, patients will undergo an additional one-year follow-up DISE.

Primary Outcome Measures

Name	Time	Method
Δ%area-of-collapse at the level of the lateral walls	Between baseline and one year follow-up	The percentage of the area of collapse at the level of the lateral walls - measured using DISE - will be calculated using ImageJ software. The percentage difference of collapse between baseline and one-year follow-up will be calculated.

Secondary Outcome Measures

Name	Time	Method
Non-invasive site and pattern of collapse	At baseline and at one-year follow-up	Non-invasive site and pattern of collapse assessed using the novel developed and validated tool at baseline and 1-year follow-up.
Δ%area-of-collapse at the level of the palate, tongue base and epiglottis	Between baseline and one year follow-up	The percentage of the area of collapse at the level of the palate, tongue base and epiglottis - measured using DISE - will be calculated using ImageJ software. The percentage difference of collapse between baseline and one-year follow-up will be calculated.
Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders	Between baseline and one year follow-up	The Δ%area-of-collapse will be specifically identified in the group of responders and the group of non-responders, to compare these two groups.
DISE-score during baseline DISE and during one-year follow-up DISE.	At baseline and at one-year follow-up	DISE-scores (pattern and degree of collapse at each site of upper airway collapse) will be scored to assess the effect of HNS on this outcome.